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3561por Li, Zhihua, Mirams, Gary R., Yoshinaga, Takashi, Ridder, Bradley J., Han, Xiaomei, Chen, Janell E., Stockbridge, Norman L., Wisialowski, Todd A., Damiano, Bruce, Severi, Stefano, Morissette, Pierre, Kowey, Peter R., Holbrook, Mark, Smith, Godfrey, Rasmusson, Randall L., Liu, Michael, Song, Zhen, Qu, Zhilin, Leishman, Derek J., Steidl‐Nichols, Jill, Rodriguez, Blanca, Bueno‐Orovio, Alfonso, Zhou, Xin, Passini, Elisa, Edwards, Andrew G., Morotti, Stefano, Ni, Haibo, Grandi, Eleonora, Clancy, Colleen E., Vandenberg, Jamie, Hill, Adam, Nakamura, Mikiko, Singer, Thomas, Polonchuk, Liudmila, Greiter‐Wilke, Andrea, Wang, Ken, Nave, Stephane, Fullerton, Aaron, Sobie, Eric A., Paci, Michelangelo, Musuamba Tshinanu, Flora, Strauss, David G.“…This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.…”
Publicado 2019
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3562por Julienne, Hanna, Lechat, Pierre, Guillemot, Vincent, Lasry, Carla, Yao, Chunzi, Araud, Robinson, Laville, Vincent, Vilhjalmsson, Bjarni, Ménager, Hervé, Aschard, Hugues“…This includes data cleaning and harmonization tools, an efficient algorithm for fast derivation of joint statistics, an optimized data management process and a web interface for exploration purposes. …”
Publicado 2020
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3563por Mathauer, Inke, Vinyals Torres, Lluis, Kutzin, Joseph, Jakab, Melitta, Hanson, Kara“…We outline four broad types of pooling reforms and discuss their potential and challenges in addressing fragmentation of health financing: (i) shifting to compulsory or automatic coverage for everybody; (ii) merging different pools to increase the number of pool members and the diversity of pool members’ health needs and risks; (iii) cross-subsidization of pools that have members with lower revenues and higher health risks; and (iv) harmonization across pools, such as benefits, payment methods and rates. …”
Publicado 2020
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3564por Koyuncu, Oguzhan, Gursoz, Hakki, Alkan, Ali, Cetintas, Hacer Coskun, Pasaoglu, Tuncay, Mashaki Ceyhan, Emel, Walker, Stuart“…CONCLUSIONS: For the TİTCK to become an international reference agency, they will need to fully implement good review practices and a structured framework for benefit-risk assessment and decision making; consider implementing verification and abridged reviews based on a reliance model and expedite the PIC/S mutual recognition process as well as become a full member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).…”
Publicado 2020
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3565“…STUDY DESIGN AND METHODS: The genotoxic and carcinogenic potential of PR‐RBCC, the reaction by‐products, and S‐300 were assessed in accordance with the International Conference on Harmonization (ICH) guidelines and performed in compliance with the Food and Drug Administration (FDA) good laboratory practice standards, 21 CFR Part 58. in vitro bacterial reverse mutagenicity and chromosomal aberration assays were performed with and without exogenous S9 metabolic activation, and in in vivo clastogenicity and carcinogenic assays using validated murine models. …”
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3566por Jones, Carolynn T., Jester, Penelope, Croker, Jennifer A., Fritter, Jessica, Roche, Cathy, Wallace, Brian, Westfall, Andrew O., Redden, David T., Willig, James“…The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions. …”
Publicado 2019
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3567“…Most MRSA isolates were community acquired in both settings, and the antimicrobial susceptibility profile was similar, suggesting transmission of community-associated MRSA into the hospital environment. Further harmonization of antimicrobial policy for the treatment of MRSA (and by extension other pathogens) should be implemented to quell ongoing transmission. …”
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3568por Vujanić, Gordan M., Gessler, Manfred, Ooms, Ariadne H. A. G., Collini, Paola, Coulomb-l’Hermine, Aurore, D’Hooghe, Ellen, de Krijger, Ronald R., Perotti, Daniela, Pritchard-Jones, Kathy, Vokuhl, Christian, van den Heuvel-Eibrink, Marry M., Graf, Norbert“…To achieve this aim, large, international, high-quality databases are needed, which dictate optimization and international harmonization of specimen handling and comprehensive sampling of biological material, refine definitions and improve logistics for expert review. …”
Publicado 2018
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3569por Desnoyers, Alexandra, Pavic, Michel, Houle, Paul-Michel, Castilloux, Jean-Francois, Beauregard, Patrice, Delisle, Line, Le Blanc, Richard, Dufresne, Jean, Boisjoly, Josie-Anne, Ethier, Vincent“…CONCLUSIONS: This retrospective study reveals an actual clinical management that is often discordant with the current recommendations and a frequent lack of follow-up after initial investigations. Harmonization of management of erythrocytosis appears to be highly desirable.…”
Publicado 2018
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3570por Karalis, Dimitrios T, Karalis, Tilemachos, Karalis, Stergios, Kleisiari, Angeliki S“…So, while genetically modified crops can provide maximum benefits in food safety and in adapting crops to existing climate change, the absence of reforms, as well as the lack of harmonization of the frameworks and regulations about the genetic modifications results in all those expected benefits of using genetically modified crops being suspended. …”
Publicado 2020
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3571por Laeremans, Hilde, Turner, Charles, Andersson, Tommy, de Juan, Jose Angel Cocho, Gerrard, Adam, Heiner‐Fokkema, M. Rebecca, Herebian, Diran, Janzen, Nils, la Marca, Giancarlo, Rudebeck, Mattias“…Inter‐laboratory analytical harmonization was demonstrated through calibration improvements.…”
Publicado 2020
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3572“…The WHO Prequalification Team could require prequalified manufacturers to make publicly available the details of their authorized distributors and facilitate a process of harmonization of quality assurance policies across all donors. …”
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3573“…Further efforts in education on optimal TDM practice as well as harmonization of service are desirable.…”
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3574por Wolf, Jayanthi, Bruno, Samantha, Eichberg, Michael, Jannat, Risat, Rudo, Sharon, VanRheenen, Susan, Coller, Beth-Ann“…It highlights focus areas for public-private partnership and regulatory harmonization that can be directly applied to current vaccine development efforts for SARS-CoV-2, while drawing attention to the need for parallel consideration of issues beyond development that are equally important to achieve global preparedness and response goals.…”
Publicado 2020
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3575por Seo, Heewon, Tkachuk, Denis, Ho, Chantal, Mammoliti, Anthony, Rezaie, Aria, Madani Tonekaboni, Seyed Ali, Haibe-Kains, Benjamin“…This portal enables the identification of synergistic drug combinations through harmonization and unified computational analysis. We integrated nine of the largest drug combination datasets from both academic groups and pharmaceutical companies, resulting in 22 507 unique drug combinations (1977 unique compounds) screened against 151 cancer cell lines. …”
Publicado 2020
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3576por Kahsay, Robel, Vora, Jeet, Navelkar, Rahi, Mousavi, Reza, Fochtman, Brian C, Holmes, Xavier, Pattabiraman, Nagarajan, Ranzinger, Rene, Mahadik, Rupali, Williamson, Tatiana, Kulkarni, Sujeet, Agarwal, Gaurav, Martin, Maria, Vasudev, Preethi, Garcia, Leyla, Edwards, Nathan, Zhang, Wenjin, Natale, Darren A, Ross, Karen, Aoki-Kinoshita, Kiyoko F, Campbell, Matthew P, York, William S, Mazumder, Raja“…The GlyGen project is a data integration, harmonization and dissemination project for carbohydrate and glycoconjugate-related data retrieved from multiple international data sources including UniProtKB, GlyTouCan, UniCarbKB and other key resources. …”
Publicado 2020
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3577“…Evolving over millenia, the human skull embodies an elegant harmonization of structure and function. The authors explored the dimensions of the neurocranium by focusing on the midline calvarial perimeter between the nasion and inion (nasioiniac arc) and its partition by bregma into 2 sub-arcs. …”
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3578por Boers, Jorianne, de Vries, Erik F. J., Glaudemans, Andor W. J. M., Hospers, Geke A. P., Schröder, Carolina P.“…This could be solved by adding PET biomarkers to randomized trials, development of imaging data warehouses, and harmonization of endpoints and procedures.…”
Publicado 2020
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3579por Tini, Giulia, Duso, Bruno Achutti, Bellerba, Federica, Corso, Federica, Gandini, Sara, Minucci, Saverio, Pelicci, Pier Giuseppe, Mazzarella, Luca“…Conclusions: This geographically and methodologically incoherent growth casts doubts on the actual feasibility of locally reaching target sample sizes and the probability of most of these trials providing reliable and transferable results. We call for the harmonization of clinical trial design criteria for COVID-19 and the increased use of larger master protocols incorporating elements of adaptive designs. …”
Publicado 2020
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3580“…Utilizing standardized case definitions and global standards for AESI will help in harmonization. Vaccine safety communication plans should be developed. …”
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